NDC 53217-300

ondansetron

Ondansetron Hydrochloride

ondansetron is a Oral Tablet, Film Coated in the Human Prescription Drug category. It is labeled and distributed by Aidarex Pharmaceuticals Llc. The primary component is Ondansetron Hydrochloride.

Product ID53217-300_9063c4fb-7de3-4a1f-8600-aee07e5c0f77
NDC53217-300
Product TypeHuman Prescription Drug
Proprietary Nameondansetron
Generic NameOndansetron Hydrochloride
Dosage FormTablet, Film Coated
Route of AdministrationORAL
Marketing Start Date2007-06-25
Marketing CategoryANDA / ANDA
Application NumberANDA077851
Labeler NameAidarex Pharmaceuticals LLC
Substance NameONDANSETRON HYDROCHLORIDE
Active Ingredient Strength8 mg/1
Pharm ClassesSerotonin 3 Receptor Antagonists [MoA],Serotonin-3 Receptor Antagonist [EPC]
NDC Exclude FlagN
Listing Certified Through2019-12-31

Packaging

NDC 53217-300-60

60 TABLET, FILM COATED in 1 BOTTLE (53217-300-60)
Marketing Start Date2007-06-25
NDC Exclude FlagN
Sample Package?N

NDC SPL Data Element Entries

NDC 53217-300-31 [53217030031]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-25
Inactivation Date2020-01-31

NDC 53217-300-30 [53217030030]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-25
Inactivation Date2020-01-31

NDC 53217-300-10 [53217030010]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-25
Inactivation Date2020-01-31

NDC 53217-300-05 [53217030005]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-25
Inactivation Date2020-01-31

NDC 53217-300-12 [53217030012]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-25
Inactivation Date2020-01-31

NDC 53217-300-06 [53217030006]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-25
Inactivation Date2020-01-31

NDC 53217-300-60 [53217030060]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-25
Inactivation Date2020-01-31

NDC 53217-300-15 [53217030015]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-25
Inactivation Date2020-01-31

NDC 53217-300-20 [53217030020]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-25
Inactivation Date2020-01-31

NDC 53217-300-13 [53217030013]

ondansetron TABLET, FILM COATED
Marketing CategoryANDA
Application NumberANDA077851
Product TypeHUMAN PRESCRIPTION DRUG
Billing UnitEA
Marketing Start Date2007-06-25
Inactivation Date2020-01-31

Drug Details

Active Ingredients

IngredientStrength
ONDANSETRON HYDROCHLORIDE8 mg/1

OpenFDA Data

SPL SET ID:4722ff63-73f6-419e-b193-6af8bc701047
Manufacturer
UNII
RxNorm Concept Unique ID - RxCUI
  • 312086
  • Pharmacological Class

    • Serotonin 3 Receptor Antagonists [MoA]
    • Serotonin-3 Receptor Antagonist [EPC]

    NDC Crossover Matching brand name "ondansetron" or generic name "Ondansetron Hydrochloride"

    NDCBrand NameGeneric Name
    0143-2422OndansetronOndansetron hydrochloride
    0143-2423OndansetronOndansetron hydrochloride
    0143-2424OndansetronOndansetron
    0143-9890OndansetronOndansetron
    0143-9891OndansetronOndansetron
    0179-0099ondansetronondansetron hydrochloride
    0179-0100ondansetronondansetron hydrochloride
    0378-0315Ondansetronondansetron
    0378-0344Ondansetronondansetron
    0378-0374Ondansetronondansetron
    0378-7732OndansetronOndansetron
    0378-7734OndansetronOndansetron
    0404-9930ONDANSETRONONDANSETRON
    67877-169ondansetronondansetron
    67877-170ondansetronondansetron
    0409-4755OndansetronOndansetron
    0409-4759OndansetronOndansetron
    68001-247OndansetronOndansetron
    68001-246OndansetronOndansetron
    68071-1547OndansetronOndansetron
    68071-1804OndansetronOndansetron
    68071-1658OndansetronOndansetron
    68071-1730OndansetronOndansetron
    68071-1904OndansetronOndansetron
    68071-1649OndansetronOndansetron
    68071-1987OndansetronOndansetron
    68071-1968ONDANSETRONONDANSETRON
    68071-1977ONDANSETRONONDANSETRON
    68071-3028OndansetronOndansetron
    68071-3195OndansetronOndansetron
    68071-3268OndansetronOndansetron
    68071-4190OndansetronOndansetron
    68071-3275OndansetronOndansetron
    68071-4191ONDANSETRONONDANSETRON
    68071-4513OndansetronOndansetron
    68071-4426OndansetronOndansetron
    68071-4115OndansetronOndansetron
    68071-4566OndansetronOndansetron
    68071-4570OndansetronOndansetron
    68071-4409OndansetronOndansetron
    68071-4594OndansetronOndansetron
    68071-4810OndansetronOndansetron
    68071-4717OndansetronOndansetron
    68083-114OndansetronOndansetron
    68083-113OndansetronOndansetron
    68071-4529ondansetronondansetron
    68258-7068OndansetronOndansetron
    68462-105OndansetronOndansetron
    68462-157OndansetronOndansetron
    68462-158OndansetronOndansetron

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